EU MDR 2020: What to Expect

EU MDR 2020: What to Expect

The European Union (EU) Medical Device Regulation (MDR) initially published in 2017, set the guidelines for EU medical device manufacturers to follow. In this article we take a look into the EU MDR, breaking down its most important parts and decoding what it means for the European region.

An Introduction to EU MDR

The EU MDR is a unified and updated form of EU’s previous two regulations: the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). Published in May 2017, the EU MDR allowed a 3-year transition period for medical device manufacturers to comply. This runway ends in May 2020, where after the EU MDR comes into full effect. After this point, every part of the medical device supply chain from manufacturers to importers and distributors in the EU, will be required to comply.

* Graph source: FAQ document on the new MDR and anticipated impact on manufacturer resources – BSI Group UK

Key Points of the 2020 EU MDR

Stricter & More Centralized Pre-Market Controls

For the case of high-risk devices, the 2020 EU MDR enforces stricter pre-market (ex-ante) controls than MDD. Apart from the new scrutiny mechanism, these controls will be conducted with the involvement of EU level expert pools; this will both enforce compliance and also bridge any gaps between authorities and medical device companies.

Inclusion of Certain Aesthetic Devices

Some aesthetic devices pose the same risk for patients as some implantable medical devices; with numerous examples of problematic results in subjects. Therefore the EU MDR will include certain devices that serve an aesthetic function (eg. implants).

Traceability & Identification

The new regulation emphasizes medical devices traceability and identification. Firstly, it enforces the usage of a unique device identification number, corresponding to a central EU database. Secondly, it introduces the concept of the implant card: a card containing information about a patients’ implanted medical devices.

Emphasis on Clinical Evidence

The EU MDR requires the demonstration of medical devices’ effectiveness through clinical evidence, regardless of whether it has been in the market or not. In order to allow for such a massive amount of clinical data to be generated, the EU MDR also introduces a new procedure for authorizing multi-center clinical investigations throughout the EU.

Strict Rules Enforcement & Coordination

From May 2020, the new regulation taking effect will be backed with a variety of actions aiming to ensure strict rules enforcement. Firstly, the notified bodies tasked with enforcing the EU MDR throughout the European countries will have reinforced criteria for designation and processes by the EU. Secondly, the EU will strengthen post-market requirements for medical device manufacturers. Lastly, there will be an effort for utilizing improved mechanisms of coordination between EU countries regarding vigilance and market surveillance.

Decoding the EU MDR

The new EU MDR is intended to improve medical devices’ quality, safety, performance, and reliability. For this reason, it emphasizes on clinical evidence, as well as transparency and traceability of medical devices throughout their lifecycle and supply chain. Moreover, it is adapted to new innovation, bridging any gaps between technology and regulations.

A factor that will have a big impact on the industry, is that clinical data is required for every medical device in circulation. This means that companies will have to bear the cost of demonstrating clinical data for every device marketed, which in some cases may not be economically feasible, for example in the case of some devices that have low sales. So a big task for medical device companies will be to conduct a cost-benefit analysis in order to determine which products are worth keeping in their portfolio and hence will require the demonstration of clinical evidence to keep in the EU market.

Share With Colleagues

[sharethis-inline-buttons]

Read More

In addition to the regulatory requirement, post-market surveillance offers an opportunity for collecting market data that can provide valuable insight into the device improvement. The purpose of this article is to focus on the benefits of conducting post-market surveillance and what is needed to establish a system to do it correctly.

We rely on these best practices for the most efficient change control board process. This ensures that the medical devices we produce are constantly improving and meeting customers’ demands while also continuously meeting existing safety and quality standards.

The FDA and other health authorities require for every medical device to meet production standards. Process validation is crucial for meeting these standards and bringing your new medical device to market.

Material selection for your medical device is so important. If done wrong it can hurt your business, but if done right, it can aid in your product’s commercial success.
Depending on your medical device, the task of selecting the right materials can be as simple as it can be daunting. Moreover, your material selection directly ties in to major design choices that you will take, based on those material’s attributes.

Testing is a crucial part of the manufacturing process which ensures your medical product delivers top results.
In today’s world health crisis and economic disarray, quality and precision of your medical products need to be a top priority. Because in medical device manufacturing, there is simply no room for shortcuts.

Subscribe to our Newsletter

Name*

Company*

Email*

By submitting the form you agree to receive relevant information, products, and services that may be of interest to you. Quasar is committed to protecting and respecting your privacy and you may unsubscribe from these communications at any time.